NCT07315048

Nursing Risk Management in Emergency SAH Surgery Using Healthcare Failure Mode and Effect Analysis(HFMEA)

Application of Healthcare Failure Mode and Effect Analysis in Nursing Risk Management of Emergency Surgery for Patients With Spontaneous Subarachnoid Hemorrhage

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 156 (actual)
• Sponsor: West China Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The investigators are testing whether a new nurse-led safety program (HFMEA) lowers problems during emergency brain-aneurysm surgery better than usual care. Adults with a sudden brain bleed (subarachnoid hemorrhage) who need urgent clipping or coil placement at the hospital are randomly placed in one of two groups: Usual nursing care, or Usual care plus HFMEA (nurses use checklists to spot and prevent risks such as re-bleeding, high brain pressure, infection, seizures). The investigators count how often any nursing-related problems happen within 30 days after surgery, how long patients stay, and how satisfied the participants and their families are. Results will show if this extra safety program should become standard practice.

Detailed description

A single-center randomized trial of adults patients undergoing emergency repair for ruptured brain aneurysms was trying to determing that if proactive "Healthcare Failure Mode and Effect Analysis" (HFMEA) could lower the rate of nursing-related adverse events from 1 in 5 patients to fewer than 1 in 15. Nurses trained in HFMEA mapped every step of care-from arrival through discharge-identified the 12 highest-risk moments (e.g., delayed pressure checks, missed re-bleeding signs), and built checklists, alert thresholds, and team huddles to stop problems before they started. aim: adding a structured, forward-looking safety drill to routine neuro-critical nursing appears to spare two out of every three avoidable complications after emergency "brain-aneurysm" surgery without extra technology or cost.

Conditions

• Spontaneous Subarachnoid Hemorrhage

Interventions

Type	Name	Description
BEHAVIORAL	HFMEA-based nursing-risk programme	Alongside standard care, these patients were managed with an HFMEA-based safety bundle. A trained nine-member team had pre-identified 12 highest-risk failure points (delayed ICP checks, missed re-bleeding signs, vasospasm, seizures, infection, etc.). From admission to day-30, nurses followed printed checklists and electronic order-sets: neuro-vitals every 15-30 min, BP target 140-160 mmHg, daily TCDs, automatic "red-flag" escalation for sudden headache/GCS drop, Triple-H protocol for velocities \>120 cm/s, prophylactic levetiracetam for severe grades, 30° head positioning, chlorhexidine/line bundles, pain-delirium scale, bed-alarm, SBAR hand-over and a 5-minute family video with teach-back. Compliance was tracked in real time and reviewed monthly; measures were updated if failure rates did not fall within six weeks.

Timeline

• Start date: 2022-03-01
• Primary completion: 2024-03-30
• Completion: 2024-04-01
• First posted: 2026-01-02
• Last updated: 2026-01-02

Locations

1 site across 1 country: China